Trial Outcomes & Findings for The Serotonin Transporter Availability for Prognosing Major Depressive Disorder (MDD) Treatment and Detecting MDD (NCT NCT02473783)
NCT ID: NCT02473783
Last Updated: 2018-01-19
Results Overview
Binding potential (BP) is a ratio of specific to non-displaceable binding (BP = (target region - cerebellum) / cerebellum)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
6 weeks (The Healthy control Group only had the scanning at baseline)
Results posted on
2018-01-19
Participant Flow
The recruitment period was from Oct-07-2011 to Nov-28-2012. The recruitment site was a psychiatric outpatient in a medical center.
The treatment group: No significant events in the study that occur after participant enrollment. The healthy control group: No significant events in the study that occur after participant enrollment.
Participant milestones
| Measure |
Treatment Group
The subjects with major depressive disorder who are screened into this study were scheduled for T1-weighted MRI (MRI examination results within 6 months before study are acceptable) prior to the visit of SPECT scans to confirm the absence of organic lesion in the brain and to co-register with SPECT images for the delineation of brain anatomical locations. After the screening visit, eligible subjects received I-123-ADAM SPECT before and after the pharmacological intervention with Sertraline HCl for a treatment period of six weeks. The subjects were observed until no clinically significant adverse events at the drug administration visits before being dismissed.
Sertraline HCl: The regimen of Sertraline HCl will be administered with starting dose from minimum 25 mg/day for 1 week and maintenance dose of at least 50 mg/day up to 200 mg/day for the rest of 5 weeks.
I-123-ADAM SPECT: The subjects underwent the SPECT scan after I-123-ADAM (185 MBq, 5mCi) IV injection.
|
Healthy Control Group
All healthy subjects had only basal I-123-ADAM SPECT scanning
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
17
|
|
Overall Study
COMPLETED
|
20
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Serotonin Transporter Availability for Prognosing Major Depressive Disorder (MDD) Treatment and Detecting MDD
Baseline characteristics by cohort
| Measure |
Treatment Group
n=20 Participants
The subjects with major depressive disorder who are screened into this study were scheduled for T1-weighted MRI (MRI examination results within 6 months before study are acceptable) prior to the visit of SPECT scans to confirm the absence of organic lesion in the brain and to co-register with SPECT images for the delineation of brain anatomical locations. After the screening visit, eligible subjects received I-123-ADAM SPECT before and after the pharmacological intervention with Sertraline HCl for a treatment period of six weeks. The subjects were observed until no clinically significant adverse events at the drug administration visits before being dismissed.
Sertraline HCl: The regimen of Sertraline HCl will be administered with starting dose from minimum 25 mg/day for 1 week and maintenance dose of at least 50 mg/day up to 200 mg/day for the rest of 5 weeks.
I-123-ADAM SPECT: The subjects underwent the SPECT scan after I-123-ADAM (185 MBq, 5mCi) IV injection.
|
Healthy Control Group
n=17 Participants
All healthy subjects (N=17) had only basal I-123-ADAM SPECT scanning.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.15 years
STANDARD_DEVIATION 12.35 • n=5 Participants
|
36.35 years
STANDARD_DEVIATION 12.72 • n=7 Participants
|
37.32 years
STANDARD_DEVIATION 12.38 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Hamilton Depression Rating Scale (HAMD) total score
|
22.90 units on a scale
n=5 Participants
|
NA units on a scale
n=7 Participants
|
22.90 units on a scale
n=5 Participants
|
|
serotonin transporter (SERT) binding potential over right basal ganglion
|
0.52 ratio
STANDARD_DEVIATION 0.28 • n=5 Participants
|
0.94 ratio
STANDARD_DEVIATION 1.32 • n=7 Participants
|
0.68 ratio
STANDARD_DEVIATION 0.86 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeks (The Healthy control Group only had the scanning at baseline)Population: All the participants in the Intention -to-treatment group completed the study. Since the healthy control group did not receive the pharmacological intervention, they underwent only the baseline assessments but not the follow-up ones. Therefore, we reported only the outcome measures of the treatment group.
Binding potential (BP) is a ratio of specific to non-displaceable binding (BP = (target region - cerebellum) / cerebellum)
Outcome measures
| Measure |
Treatment Group
n=20 Participants
The subjects with major depressive disorder who are screened into this study were scheduled for T1-weighted MRI (MRI examination results within 6 months before study are acceptable) prior to the visit of SPECT scans to confirm the absence of organic lesion in the brain and to co-register with SPECT images for the delineation of brain anatomical locations. After the screening visit, eligible subjects received I-123-ADAM SPECT before and after the pharmacological intervention with Sertraline HCl for a treatment period of six weeks. The subjects were observed until no clinically significant adverse events at the drug administration visits before being dismissed.
Sertraline HCl: The regimen of Sertraline HCl will be administered with starting dose from minimum 25 mg/day for 1 week and maintenance dose of at least 50 mg/day up to 200 mg/day for the rest of 5 weeks.
I-123-ADAM SPECT: The subjects underwent the SPECT scan after I-123-ADAM (185 MBq, 5mCi) IV injection.
|
Healthy Control Group
All healthy subjects had only basal I-123-ADAM SPECT scanning.
|
|---|---|---|
|
The SERT Binding Potential (BP) --(Only the Treatment Group Was Assessed)
|
0.34 a ratio of target region to background
Standard Deviation 0.26
|
—
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: All the participants in the Intention -to-treatment group completed the study. Since the healthy control group did not receive the pharmacological intervention, they underwent only the baseline assessments but not the follow-up ones. Therefore, we reported only the outcome measures of the treatment group.
The questionnaire is designed for adults and is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. It contains 17 items to be rated. Each item on the questionnaire is scored on a 3 or 5 point scale. The range of the total score (summed) is from 0 to 52.The higher total score suggests the more severe depression.
Outcome measures
| Measure |
Treatment Group
n=20 Participants
The subjects with major depressive disorder who are screened into this study were scheduled for T1-weighted MRI (MRI examination results within 6 months before study are acceptable) prior to the visit of SPECT scans to confirm the absence of organic lesion in the brain and to co-register with SPECT images for the delineation of brain anatomical locations. After the screening visit, eligible subjects received I-123-ADAM SPECT before and after the pharmacological intervention with Sertraline HCl for a treatment period of six weeks. The subjects were observed until no clinically significant adverse events at the drug administration visits before being dismissed.
Sertraline HCl: The regimen of Sertraline HCl will be administered with starting dose from minimum 25 mg/day for 1 week and maintenance dose of at least 50 mg/day up to 200 mg/day for the rest of 5 weeks.
I-123-ADAM SPECT: The subjects underwent the SPECT scan after I-123-ADAM (185 MBq, 5mCi) IV injection.
|
Healthy Control Group
All healthy subjects had only basal I-123-ADAM SPECT scanning.
|
|---|---|---|
|
Hamilton Depression Rating Scale (HAM-D) Total Scores
|
5.25 units on a scale
Standard Deviation 4.01
|
—
|
SECONDARY outcome
Timeframe: assessed at -5~0 days and 6 weeks ±5 days, -5~0 days reported (I-123-ADAM SPECT scan)Population: All the participants in the Intention -to-treatment group completed the study.
Pain Scores as measured by the Visual Analog Scale (0-10) for the tolerability of injection of I-123-ADAM solution. Higher values represent a worse outcome.
Outcome measures
| Measure |
Treatment Group
n=20 Participants
The subjects with major depressive disorder who are screened into this study were scheduled for T1-weighted MRI (MRI examination results within 6 months before study are acceptable) prior to the visit of SPECT scans to confirm the absence of organic lesion in the brain and to co-register with SPECT images for the delineation of brain anatomical locations. After the screening visit, eligible subjects received I-123-ADAM SPECT before and after the pharmacological intervention with Sertraline HCl for a treatment period of six weeks. The subjects were observed until no clinically significant adverse events at the drug administration visits before being dismissed.
Sertraline HCl: The regimen of Sertraline HCl will be administered with starting dose from minimum 25 mg/day for 1 week and maintenance dose of at least 50 mg/day up to 200 mg/day for the rest of 5 weeks.
I-123-ADAM SPECT: The subjects underwent the SPECT scan after I-123-ADAM (185 MBq, 5mCi) IV injection.
|
Healthy Control Group
n=17 Participants
All healthy subjects had only basal I-123-ADAM SPECT scanning.
|
|---|---|---|
|
Safety Assessments - the Tolerability of Injection of I-123-ADAM Solution
|
1.52 units on a scale
Standard Deviation 2.76
|
0.88 units on a scale
Standard Deviation 1.96
|
Adverse Events
Treatment Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Healthy Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Group
n=20 participants at risk
The subjects with major depressive disorder who are screened into this study were scheduled for T1-weighted MRI (MRI examination results within 6 months before study are acceptable) prior to the visit of SPECT scans to confirm the absence of organic lesion in the brain and to co-register with SPECT images for the delineation of brain anatomical locations. After the screening visit, eligible subjects received I-123-ADAM SPECT before and after the pharmacological intervention with Sertraline HCl for a treatment period of six weeks. The subjects were observed until no clinically significant adverse events at the drug administration visits before being dismissed.
Sertraline HCl: The regimen of Sertraline HCl will be administered with starting dose from minimum 25 mg/day for 1 week and maintenance dose of at least 50 mg/day up to 200 mg/day for the rest of 5 weeks.
I-123-ADAM SPECT: The subjects underwent the SPECT scan after I-123-ADAM (185 MBq, 5mCi) IV injection.
|
Healthy Control Group
n=17 participants at risk
All healthy subjects had only basal I-123-ADAM SPECT scanning.
|
|---|---|---|
|
Eye disorders
conjunctivitis
|
5.0%
1/20 • Number of events 1 • 6 weeks
The healthy control group did not receive the pharmacological intervention, they underwent only the baseline assessments and were only monitored for adverse events at baseline.
|
0.00%
0/17 • 6 weeks
The healthy control group did not receive the pharmacological intervention, they underwent only the baseline assessments and were only monitored for adverse events at baseline.
|
Additional Information
Dr. Chin-bin Yeh
Tri-Service General Hospital, National Defense Medical center
Phone: 886-2-87923311
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place